MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number ECH060040

Device Problems Peeled/Delaminated (1454); Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

It was reported to gore that the patient underwent surgical treatment for a dialysis shunt in the left forearm with a gore® acuseal vascular graft.It was stated that the vascular graft was implanted on (b)(6) 2021, as a loop shunt for av access.On (b)(6) 2021, the shunt occluded.The physician stated that a delamination of the graft appeared to be seen.The graft remained implanted.Reportedly, the patient received a central venous line and is treated in the (b)(6).

Manufacturer Narrative

As the device remains implanted, no further investigation of the device can be performed.An image was provided for further evaluation.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

Product history review: a review of the manufacturing - and heparin coatings records indicated the lots met all pre-release specifications.As the device remains implanted, no further investigation of the device can be performed.Imaging evaluation: the image provided by the complainant reflects the case description but could not be confirmed.The evaluation found no anomalies attributable to the manufacture of the device.With the information provided to gore, the cause of the reported issue could not be established.In the instruction for use for the gore® acuseal vascular graft the following is stated: technical information: patients should be carefully monitored when using gore® acuseal vascular grafts for vascular access.Puncture sites must be adequately separated when repeated needle punctures of the graft are necessary.Multiple punctures in the same area may lead to disruption of the graft material or formation of a perigraft hematoma or pseudoaneurysm.Possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis; mechanical disruption, formation of pseudoaneurysms due to excessive, localized, or large needle punctures.

Manufacturer Narrative

H6: evaluation codes medical device problem code a040506 was added.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14742728
• MDR Text Key: 295351950
• Report Number: 2017233-2022-03021
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2023
• Device Catalogue Number: ECH060040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 06/29/2022; 11/02/2022
• Supplement Dates FDA Received: 07/28/2022; 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Male